Did you know the United States and New Zealand are the only nations that permit direct-to-consumer (DTC) pharmaceutical ads?

A decade ago, Kaiser Family Foundation found that every $1 the pharmaceutical industry spends on direct-to-consumer (DTC) advertising yields $4.20 in drug sales, and that DTC ads were responsible for 12 percent ($2.6 billion) of the total growth in drug spending in 2000.

Groups such as Our Bodies Ourselves and the National Women’s Health Network have long argued for stricter regulation and elimination of DTC drug advertising, due to the tendency to overstate drug benefits and understate risks in order to increase pharmaceutical companies’ profits.

There is some minimal governmental regulation of traditional DTC ads (i.e., print, TV) with respect to the claims companies can make and information they must provide — although the level of oversight is insufficient to fully protect consumers from misleading and manipulative claims about drugs.

For web-based DTC advertisements, however, there is even less oversight and more mixing of advertising and information content, increasing the risk that consumers will be confused and misled.

This is the case with fertility clinic websites, which represent a multibillion dollar industry. Evidence suggests that fertility clinics’ approaches to online advertising present significant problems for consumers seeking objective information about success rates and clinic practices.

Since 1992, as a result of pressure by consumers and organizations, U.S. clinics have been required to report their success rates to the Centers for Disease Control and Prevention (CDC), which publishes this data (see reports on assisted reproductive technologies).

More than 146,000 cycles of assisted reproductive technologies (ART) are reported to the CDC each year (primarily in vitro fertilization attempts), meaning that there are many consumers who are having these procedures. But, consumers looking for fertility-related information and/or providers are more likely to visit fertility clinic websites than the CDC website.

Sadly, these clinic sites too often try to influence consumers with misleading information about their ability to create successful pregnancies. ART is expensive (averaging $12,400 per cycle, with many patients requiring two or more cycles) and often is not covered by insurance, so it is natural for patients to seek a provider who can maximize their chance of success.

Yet a recent analysis of web content from 372 U.S. fertility clinics (out of a total of 381 clinics) suggests that the success rates being promoted are not based on reputable practices and/or standards.

The analysis examined websites of the clinic members of the Society for Assisted Reproductive Technology (SART), which represents most U.S. fertility clinics. SART’s guidelines require clinics to compare their success rates only to the national average, but 46 percent of the clinics violated this policy.

Of those, 47 percent described their success rates as “superior” or “among the best,” without indicating what they were comparing themselves to (which is prohibited under SART guidelines). Over one-third (39 percent) of clinics that provided a success rate failed to describe how the rate was calculated (as SART requires), making it impossible for potential clients to gain a meaningful understanding of the rates.

Clinics also fail to meet the American Medical Association’s (AMA) guidance on website content; one study found the majority of fertility clinic websites failed to meet basic  guidelines such as describing how they protect patient’s privacy. The AMA does not investigate websites’ compliance or issue non-compliance penalties, however, and the only consequence for noncompliance with SART’s guidelines is for clinics to lose their membership (not a very significant penalty).

Consumers face challenges when trying to evaluate clinic performance in other areas as well. ART clinic sites frequently use non-medical and non-verifiable content and advertising tactics to entice potential patients. Many use words like “dream” (30 percent of websites) on their homepages. Many mention their excellent technology (84 percent), personal approach (75 percent), and high-quality doctors (70 percent) — factors that, while important, do not provide objective information by which to compare clinics.

An example of non-specific information is provided by a clinic that calls its prices “competitive” and says it “lacks hidden fees,” but does not provide an actual fee list.

Concerns about ART advertising date back to the field’s beginning in the late 1990s. Then, as now, concerns include the commercialization of medicine, inability to assess service quality, and a lack of accountability. Studies have found that clinics fail to provide objective measures of success; to note when their procedures are experimental (and may have lower success rates); and to generally comply with SART guidelines.

The only thing that’s new is that consumers now have ready access to misleading and poor information online, making it easier for consumer to access and, therefore, to be misled.

What can be done to help patients navigate the maze of on-line fertility clinic information? First, consumers should view these sites with a critical eye, recognizing that words like “miracle” and photos of smiling babies are intended to evoke specific feelings and encourage spending lots of money at a specific clinic. The sites should be considered to be advertisements rather than sources of accurate, verifiable medical information. Consumers should consult the CDC data (recognizing that comparisons may be difficult and clinics may select patients in ways that influence their rates).

Second, we need better oversight of clinic website content, including independent assessment and disclosure of how well clinic websites meet industry guidelines. SART and the American Society for Reproductive Medicine should establish new guidelines that reflect how clinics actually advertise (e.g., online), commit resources to member education, and impose significant consequences for non-compliance.

Any new guidelines should include the use of social media (like Facebook), used by about one-third of clinics already to reach potential customers. More broadly, Federal restrictions and regulations on DTC marketing should include web-based and social media, as well as TV ads and other forms of advertising.

A version of this article was originally published in The Women’s Health Activist, the newsletter of the National Women’s Health Network, and is adapted with permission. 

Related: Our Bodies Ourselves resources on infertility and assisted reproduction

by Hanna Pennington 

No one ever really wants to take health class; it’s a required course, something people try to get out of the way so they aren’t that about-to-graduate senior who still has to take health. And that’s because at most high schools, health class doesn’t offer much — and everyone knows it.

I spent 80 minutes every other morning in health class during the second semester of my sophomore year, and when faced with an end-of-the-year survey about the class, I realized that the time had not been “spent,” but wasted.

We had not discussed birth control; condoms were the only form of contraception mentioned, and they came up only in the context of preventing STIs. A significant number of high school students are already taking hormonal birth control, like the pill, for a variety of reasons, whether to regulate hormone imbalances that can cause acne, reduce the pain of bad menstrual cramping, or because they are having sex, but the pros and cons of the pill were never addressed.

Through reading “Our Bodies, Ourselves” and other feminist websites and books, I have learned about many types of birth control. But this is because I care about this kind of thing. Most people don’t know what they should have been taught until it’s too late.

Another way in which my health class was insufficient, and also offensive, was that LGBTQ people were only mentioned in the context of HIV/AIDS, which we learned about by watching the film “And The Band Played On.” There was no other discussion.

As a bisexual person, I felt shortchanged. I sought out resources online, much the way I did with birth control, but again, this didn’t make up for the lack of class information. The majority of high school students are straight, but it is important to provide for those who aren’t, or who might be questioning. It is important to learn about how to have safe gay sex, not only safe straight sex; that information is a lot harder to find, unless you know where to look.

Related: A “Real” Sex Ed Story: A Teenager Recalls Lessons From “Our Whole Lives”

Another issue we did not discuss is consent. People need to learn not only that it’s OK to say no, but that enthusiastic consent is the key to happy, healthy sex (in fact, there’s a petition to make consent a mandatory part of sex-ed in public schools).

Abuse, both physical and sexual, should also be discussed. And resources should be provided for everything: where to get help if you’re being abused, where to purchase prescription contraception at a discount, where to get tested for STIs, and the number for the closest Planned Parenthood, for starters.

Finally, we never discussed masturbation. It is important for students to know that instead of it being something unholy or disgusting, masturbation is a perfectly healthy and important way to explore one’s own body and sexuality.

According to research by the Sexuality Information and Education Council of the United States (SIECUS), comprehensive sex education is more effective in preventing teen pregnancy than abstinence-only education. In her 2008 New Yorker article “Rex Sex, Blue Sex,” Margaret Talbot analyzed the differences in sexual patterns of teenagers living in different parts of the country, including the prevalence of teen pregnancies and STIs and use of contraception.

In conservative red states, where abstinence-only education is the norm and religion dictates much of the discourse, teenagers have sex earlier, usually without protection. In more liberal blue states, where there is often (but not always) more comprehensive sex education, teenagers wait longer to have sex and use protection more often when they do.

Although I live in blue-state New York, my health class was not all that. It is possible to acknowledge teenagers being sexual without encouraging it, but our teachers didn’t acknowledge any part of it. It is irresponsible to teach the class assuming that everyone is and will remain abstinent until marriage.

The 2009 documentary “Let’s Talk About Sex” examines young people’s attitudes toward and knowledge of sex and sexuality, comparing America’s largely insufficient programs to those of places like the Netherlands, where parents and children talk openly about sex (and which have lower rates of teen pregnancy and STIs).

Although I was briefly tempted to move overseas, there are comprehensive sex-ed curriculums in the United States, even if they can be hard to find.

One of my friends attends Rye Country Day School in Rye, N.Y. A program there encourages underclassmen to ask upperclassmen leaders whatever they want about sex, relationships, and so on. I was really impressed when I first heard about this, as it fosters an environment that removes shame from asking questions, which is how people get the answers they need.

At Manhattan Country School, there is a sex-ed curriculum, designed by Dr. Cydelle Berlin, that involves theater arts and peer education. Trained actors answer questions while in character. There is a box in every classroom in which students can leave anonymous questions.

The Unitarian Universalist Church, instead of strictly discouraging or not discussing sex as other churches often do, teaches a K-12 sex ed curriculum called “Our Whole Lives.” As stated on the website, the program “not only provides facts about anatomy and human development, but also helps participants clarify their values, build interpersonal skills, and understand the spiritual, emotional, and social aspects of sexuality.”

This curriculum is based on SIECUS’ “Guidelines for Comprehensive Sexuality Education,” which spans the same age range and includes such important topics as body image, gender identity, masturbation, abortion, and sexuality and society.

When reading this curriculum, I was pleasantly surprised how enlightened, inclusive, and accurate it was. But this should not be surprising; accurate language should be the norm.

It is bad enough that decisions about women’s health are made mostly by male politicians, but it is even more disheartening when you realize that some of them have no idea what they’re talking about. High school students aren’t the only ones who need basic education about reproduction, but it’s a good place to start.

Hanna Pennington is a high school senior in New York whose first foray into feminist activism was at age 7, when she wrote a letter to a children’s magazine protesting the omission of Sacagawea in an article about the Lewis and Clark Expedition. 

The Guttmacher Institute recently published a report examining how access to and the use of effective birth control affects women’s lives.

“The Social and Economic Benefits of Women’s Ability to Determine Whether and When To Have Children“ reviews more than 66 studies over the past 30 years. According to researchers, access to contraception and avoidance of unplanned pregnancy have led to:

• increases in young women obtaining at least some college education
• increases in college-educated women pursuing advanced professional degrees
• increased participation in the workforce by women
• increases in women’s earning power and decreases in the gender gap in pay

The researchers identify several gaps in the literature as well as areas where additional research is needed, such as how contraception benefits older women and women with low incomes, of racial and ethnic minorities, single mothers, and women with other sociodemographic factors that might prevent them from getting the full benefits of contraception.

The authors conclude with an important call for ongoing efforts to enhance access to contraception:

Clearly, access to reproductive health care and the recognition of reproductive rights cannot be addressed in isolation from the rest of an individual’s life, or from the rest of society’s inequities. Rather, policies and programs that advance contraceptive access and those that affect whether a woman is still able to achieve her life goals if and when she becomes a mother should be considered as part of a greater whole.

By helping women and couples, regardless of background or income, determine and exercise their own reproductive choices, government and organizational policies can help advance broader economic equality and social justice for individual women, families and society.

The report is available online as a PDF; a summary with links to more information is also provided. Also check out OBOS’s Brief History of Birth Control and discussion of Global Access to Birth Control.

While cesarean rates (which reached an all-time high in 2007) are known to vary widely by state, they also vary quite a bit by hospital. One common explanation for this has been that different hospitals have different c-section rates because they see different types of patients – patients who are sicker or healthier, or more likely to have complications requiring cesarean.

In an article published in PLOS ONE, researchers report findings from a study designed to look at other factors that influence cesarean rates. The authors looked at birth certificate and hospital discharge data in Massachusetts to determine which factors were linked to cesarean rates at each hospital.

The researchers focused on first births of single, non-breech births in Massachusetts hospitals from the beginning of 2004 through the end of 2006. They report that at the hospital level, the percent of cesarean deliveries varied between 14.0 percent and 38.3 percent (average of 26.4 percent). Then they adjusted for health and sociodemographic factors, like labor induction and maternal age, that are linked to higher rates of cesarean.

They found, predictably, that individual risk for cesarean varied by demographic, socioeconomic, pregnancy, and preexisting medical conditions. After they adjusted for these factors, though, there was still significant variation in rates between hospitals that could not be explained by those medical and personal risk factors.

While the authors did not set out to explain why this variation occurred, they note that it has been observed in other studies (such as in Arizona, and in military hospitals), and that contributing factors may include liability- and insurance-related factors, whether a woman delivers at a teaching hospital, the provider’s approach to delivery, hospital practices related to labor induction and augmentation, and others. They conclude that additional research is needed on hospital characteristics to figure out what is driving variability between hospitals and reduce the influence of non-clinical factors on women’s risk of cesarean delivery.

Finding out the rate of cesarean sections at any given hospital can be difficult, as is understanding why the rates are high in any given situation. At her  website, CesareanRates.com, consumer advocate Jill Arnolds attempts to bring together the available statistics, allowing users to compare cesarean rates by state and by individual hospital.

If you’re interested in finding out more about what you can do increase your chances of having a vaginal birth, see this tip sheet from Childbirth Connection.

There’s been much discussion lately about routine mammogram screening for breast cancer, including, according a new study, the very real psychological harm connected to false positive readings.

Complicating this information further is the issue of breast density. Dense breasts have less fat and more glandular and connective tissue. While some women’s breasts become less dense and more fatty as they age, other women’s breasts remain relatively dense.

Why does this matter? Having dense breast tissue makes it harder to obtain an accurate reading of mammograms. It also increases a woman’s risk of developing breast cancer.

However, questions remain about what women should do with that information. In fact, recent research suggests that actual risk of death from breast cancer is not increased for women with denser breast tissue.

Despite a lack of certainty about how dense breast tissue affects health outcomes, a handful of states have mandated that providers discuss breast density with women. On April 1, California will become the fifth state with a breast density notification law in place. Similar bills have been introduced in other states.

At the federal level, the Breast Density and Mammography Reporting Act was introduced in Congress in 2011, but never made it out of committee. It, too, would require that women be told about breast density, the correlation with cancer, and that they might benefit from supplemental screening tests.

It’s not clear, however, if additional tests would even help.

The authors of a recent commentary in the medical journal Radiology note that while explaining the increased risk of cancer to women with dense breasts “seems ethical, reasonable, and appropriate,” there is little known about what additional follow-up might help those women.

They conclude that “the advocacy push to legislate mandatory reporting of breast density and possible adjunct screening for all women with heterogeneously or extremely dense breasts is far outpacing the reporting of evidence that supplemental screening may provide better outcomes for these patients.”

They also raise concerns about invasive procedures: “Because some cancers detected at screening may not go on to cause symptoms or death, additional interventions performed on these excess cancers would only increase morbidity for these patients.”

These concerns are similar to those raised about routine mammography in younger women — that more testing may increase harm to women from extra procedures, while not actually increasing survival rates.

Breast Cancer Action addressed mandatory notification laws in late 2012, coming down against such legislation:

Unfortunately, the importance of breast density is still not well understood and as a result there is no clear action for women who receive this information. Breast Cancer Action believes that medical practitioners should discuss all aspects of a woman’s health with her and we do not believe legislation is the appropriate way to address the issue of breast density. We believe resources and energy are better spent on working for better medical care and understanding the ways to prevent breast cancer in the first place.

Laura Newman, a medical journalist, has also looked at this issue. Her Patient POV blog has a couple of clear, useful posts, including “Are Dense-Breast, Right-to-Know Laws Helpful?” and “Is the Bar High Enough for Screening Breast Ultrasounds for Dense Breasts?”

Where does this leave women, especially those who may be told they have dense breast tissue as a result of one of these new laws? Unfortunately, there is no clear answer right now.

Hey Austin and Chicago! Judy Norsigian, founder and executive director of Our Bodies Ourselves, and film director Carol Ciancutti-Leyva are heading to your cities to host a screening and discussion of the acclaimed documentary “Absolutely Safe,” examining the controversy over breast implant safety. The screenings are free and open to the public.

The Austin event kicks off at 6 p.m. on Tuesday, March 19, at the University of Texas at Austin AVAYA Auditorium (ACE 2.302).

The Chicago screening takes place on Thursday, March 21, at 5:30 p.m. at the UIC School of Public Health auditorium. Registration is requested by UIC.

Interested in learning more about OBOS’s work and women’s health issues? Attend a private house party with Judy Norsigian in Austin (Monday, March 18) or in Chicago (Wednesday, March 20), where she’ll be joined by Christine Cupaiuolo, managing editor of the 2011 edition of “Our Bodies, Ourselves.” To learn more about these special events, email office AT bwhbc.org or call (617) 245-0200 x10. 

Here’s more about this unforgettable film; also read what Ciancutti-Leyva wrote about why and how she undertook this project. Hope you’ll join us in person!

At a time when more women than ever are getting breast implants, fewer voices than ever seem to be asking “Why?” And fewer still are asking “Are they safe?” ABSOLUTELY SAFE takes an open-minded, personal approach to the controversy over breast implant safety. Ultimately, ABSOLUTELY SAFE is the story of everyday women who find themselves and their breasts in the tangled and confusing intersection of health, money, science and beauty.

At its heart, ABSOLUTELY SAFE is driven by the experience of the filmmaker’s own mother. Diagnosed in 1974 with breast tumors, Audrey Ciancutti underwent a double mastectomy with silicone-implant reconstruction surgery. A year later, her implants ruptured, and soon after, her health steadily declined. Like thousands of other women, Audrey believes her debilitating illnesses—joint pain, chronic fatigue, scleroderma — are linked to her breast implants; however, most doctors and researchers deny this link. Among the debate by plastic surgeons, toxicologists, attorneys, implant manufacturers, whistle blowers, government officials and activists, ABSOLUTELY SAFE introduces more everyday women like Audrey who make choices about their breasts in our appearance driven culture.

Arguments are scheduled to be heard by the Supreme Court on April 15 on the Myriad Genetics case, which will challenge patents held on human genes, especially the BRCA1 and BRCA2 genes known to increase breast cancer risk.

The suit charges that leaving human genes in the hands of corporations limits diagnostic testing and research that could lead to cures, and limit women’s options for medical care.

Breast Cancer Action is holding a rally on April 15, the day the case is heard, to stand up for women’s health and against corporate control of our genes. It begins at 9:30a.m and will take place on the steps of the Supreme Court. To find out more, follow @BCAction on Twitter.

Our Bodies Ourselves is a co-plaintiff in the lawsuit challenging these gene patents. For further information and resources, see these previous posts:

• OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents
• Breast Cancer Gene Patents Invalidated
• Take Back Our Genes Campaign Fights Restrictive Gene Patenting
• ACLU Survey for Women Who Have Been Advised to Get BRCA Genetic Testing

Forty years ago today, The New York Times reviewed “Our Bodies, Ourselves” under the headline “Thinking About the Thinkable.”

It’s fascinating to see how the book was received in the mainstream press — and, in this case, how one of the most prominent book reviewers of the late 20th century, Christopher Lehmann-Haupt, approached the text.

I admit I was surprised to see his byline when I looked up the review, after being alerted to the anniversary on Twitter via @Feministory.

Lehmann-Haupt was the senior daily book reviewer for the Times back then, a position he held from 1969 to 2001. But as he acknowledges up front, you wouldn’t necessarily expect to see the first women’s health book of its kind reviewed by a man.

He writes that he took on the review “first, because the book looked useful and I wanted an excuse to read it carefully, and second, because those members of the movement I respect have often argued that women’s liberation means men’s liberation, and it is an argument I am willing to try on.”

His perspective is laudable, although sometimes Lehmann-Haupt seems to forget it’s not really for or about him.

The review is of the first edition published by Simon & Schuster. Prior to 1973, the book had appeared in two other formats: In 1970, a group of women printed and stapled together a 193-page course booklet, “Women and Their Bodies,” based on their own research and exploration of women’s health and social/political issues. The booklet is available online (download “Women and Their Bodies” [PDF]).

In 1971, they changed the name to “Our Bodies, Ourselves” — to emphasize women taking full ownership of their bodies — and New England Free Press republished it that same year, selling 250,000 copies, mostly by word of mouth. That edition was one of 88 books selected by the Library of Congress for the 2012 exhibit “Books That Shaped America.”

The strong demand taxed the small New England Press, which is when Simon & Schuster stepped in (read the preface to the 1973 edition).

By then the need for the book had been well established; “it doesn’t much matter whether male reviewers like it or not,” Lehmann-Haupt wrote. That does not, however, stop him from dragging out the discussion:

But do I like it? you are still wondering. Let me duck the question a moment longer by saying that since the book was written collectively — with, for example, “A Boston gay collective” contributing the chapter on Lesbianism, “In Amerika They Call Us Dykes”; and several older women helping out on the chapter covering menopause — it was never expected that everyone would be pleased with all the contents, not even the women who put the book together.

Nor does he have a problem with declaring what any “sensible” woman would appreciate:

I don’t see how any sensible woman — even an antifeminist one — could fail to be enlightened by the book’s lucidly informative chapters on “The Anatomy and Physiology of Reproduction and Sexuality,” on nutrition, exercise, venereal disease, childbearing and postpartum emotional problems; or even by the philosophy that informs them, to wit, that knowledge of one’s body is essential to control of one’s body, and that control of one’s body is essential to living in contemporary America. (As you will see if you read the book, it’s a more radical idea than it may sound.)

He makes 40 years seem like like yesterday.

And then:

On the other hand, I can imagine that some women — even halfway liberated ones — may not agree with the book’s extreme open-mindedness on the questions of birth control and abortion, or its specific conclusion that “it is a myth that the infant will be psychologically damaged unless the mother is always present.”

Let that last line sink in for a moment.

Lehmann-Haupt concludes with his “quibbles” and his findings:

I am still trying to dovetail all the talk about “living less in our heads” and responding “to our feelings” with the book’s overriding message that women must know and think about their bodies in order to get control of their lives. (I’m sure there’s a way to reconcile these two messages, but trying to find it has me climbing an epistemological wall.)

But I learned a great deal from this book that I did not know before, or had somehow forgotten. And if the authors are correct in their belief that one of the major reasons why men oppress women is because “of the male fear and envy of the generative and sexual powers of women” — and I think they are — why then it will do no harm at all for men to read “Our Bodies, Ourselves” and expend a little rational thought on these powers. Nor will it do much harm for a male to review it.

For all my quibbles, to have a man in 1973 so willing to join the feminist movement is a credit to him — and to the book.

The ninth and newest edition of “Our Bodies, Ourselves,” published in 2011, was named one of Library Journal’s best consumer health books of the year. Find out what the fuss is (still) all about.

In late February, the FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant for breast augmentation in women age 22 and older and breast reconstruction in women of any age.

It surprises us that the FDA did not hold a public Advisory Committee Meeting prior to approval. All we found was the press release, which notes the FDA based its approval on seven years of data from 941 women, a relatively small number:

Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection. In addition, investigators observed fissures (cracks) in the gel of some Natrelle 410 implants. This is a characteristic called gel fracture and is unique to this implant.

The issue was not reported in a six-year study of the Natrelle silicone gel implant, published in the August 2012  issue of  Aesthetic Surgery Journal.

That study was funded by Allergan (and led by a researcher who is a paid consultant, royalty recipient and stockholder in Allergan). Studies paid for by manufacturers are not uncommon, but it makes it harder to tell what sorts of biases there might be in the results. In this case, researchers noted that between 19 and 43 percent of women required additional surgery — the number varied by whether the implants were for augmentation, revision or reconstruction. The researchers also reported that between 5 and 14 percent of patients experienced an implant rupture.

The FDA also did not post approval documents online, so the seven-year data, which would possibly include newer research results, is not readily available to the public.

The FDA has long known about the temporary nature of silicone gel breast implants. In 2011, the FDA released a report on their safety, urging women to “assume that you will need to have additional surgeries” — a point the FDA reiterated in the press release announcing approval of the Naturelle 401:

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”

Diana Zuckerman, president of the National Research Center for Women & Families, criticized the approval, questioning why a public meeting wasn’t held and noting that “Allergan has not done a good job of doing post-market studies once their implants have been approved.”

“It seems likely that the FDA decided it was better to hide this information than to make it public at a meeting where implant patients could talk about the health problems that have been caused by these implants,” wrote Zuckerman, who has written frequently about the safety of breast implants.

The FDA is requiring additional “post-approval” studies on several aspects of the Natrelle 410, including study of long-term outcomes in more than 2,000 patients followed over 10 years; rare adverse events in a study to include at least 11,500 women; collection of additional safety and effectiveness data; improvement of the format and content of the patient labeling; and analysis of implants that are removed and returned to the manufacturer.

The additional studies will help determine the risks of these implants. Unfortunately, the results won’t be known for years. In the meantime, women will have implants in their bodies  that have not undergone a rigorous review.

While most birth control pills currently available in the United States are safe for most women, some newer pills that contain the progestin drospirenone have come under scrutiny because of an increased risk of blood clots. Birth control pills containing drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz and Zarah.

The European Medicines Agency (EMA) announced late last month that it would take another look at so-called third and fourth generation oral contraceptives, including those with drospirenone, and consider whether use of these drugs should be limited.

The agency also plans to review whether current product information is enough to properly inform women and their health care providers of the risks. The agency has also said, though, “There is no reason for any woman to stop taking her contraceptive” — a rather confusing message for women wondering if they should switch to other types of pills.

The EMA previously reviewed whether this type of drug (specifically Yaz) could be marketed for use in preventing acne, but decided it could not based on concerns about the clot risk; it factored in that if women who no longer needed contraception or no longer needed the acne treatment continued on the drug, they would be exposed to unnecessary additional risk.

The U.S. FDA also did a review of pills with drospirenone, and is requiring language about the higher risk of blood clots to be added to the labels. As we noted last year, women’s health experts, including OBOS, have concerns about that review, and about leaving these pills on the market when safer alternatives exist.

That’s a key point in considering pills with drospirenone. While the risk of clots is small, we know the risk is higher with these pills than with other oral contraceptives. As one expert testified before the FDA, “I don’t usually vote against choices, but this time I did. And the reason is because on the benefit side, I didn’t see any improved benefit over the existing available choices.”

In the Women’s Health Activist newsletter in spring of 2012, Amy Allina, program and policy director of the National Women’s Health Network, wrote:

The question for a woman is, what should she weigh these risks against? As some have pointed out, the blood clot risks of pregnancy are greater than those of drospirenone pills. Is that the right basis of comparison? The Network does not believe it is. There are other, safer, ways women can avoid the risks of pregnancy – including contraceptive pills that don’t contain drospirenone. Drospirenone pills don’t provide a unique benefit over other available contraceptive pills. We’re also concerned that most women using drospirenone pills are unaware that other contraceptive pills are safer.

The NWHN has asked the FDA to remove these pills from the market. Allina wrote: “We believe that women who are looking for contraceptive options to help them postpone or prevent pregnancy should not be unnecessarily exposed to a higher risk of blood clots when there are safer alternatives with the same benefits available.”

By Phil Galewitz | Kaiser Health News

For decades, doctors have been warned about the dangers of delivering babies early without a medical reason. But the practice remained stubbornly persistent.

Erin Thornton, Judy Norsigian, Rep. Jim McGovern, and Christy Turlington Burns

Last fall, following a sex-ed road trip with The Ladydrawers to deliver “Our Bodies, Ourselves” to former Rep. Todd Akin (of “legitimate rape” fame), Our Bodies Ourselves launched Educate Congress, a campaign to deliver the book to all members of Congress and key administration officials.

The basic premise: Everyone deserves access to accurate information concerning women’s reproductive and sexual health — especially those who write the laws.

Today OBOS kicked off delivery of the book, as Judy Norsigian, OBOS executive director and one of the original authors of “Our Bodies, Ourselves,” hand-delivered copies of the newest edition to about 20 legislators and staff members.

The point was made that the problem isn’t just poorly chosen words; rather, a lot more needs to be done to advance evidence-based health policy.

Norsigian walked the halls of Capitol Hill with Christy Turlington Burns, founder of Every Mother Counts, and EMC’s executive director, Erin Thornton. They submitted EMC’s petition to female members of Congress, asking them to support policies that protect the health and well-being of girls and women around the world, especially those that will reduce infant and maternal mortality rates.

Doing this on the day that the House finally passed the Violence Against Women Act made it particularly poignant.

NWHN interns Allyson Reddy and Grace Adofoli with Judy Norsigian and Rep. Chellie Pingree

Thanks to Allyson Reddy and Grace Adofoli, interns at the National Women’s Health Project, the book launch was a success. More books will be delivered in the coming weeks, until every member of Congress has, in their office, up-to-date information they can rely on when drafting bills that have a real impact on girls and women.

A big thank you to the supporters of Educate Congress! And a special shout out to fellow road-trippers Anne Elizabeth Moore, Rachel N. Swanson, Nicole Boyett and Sara Drake; Congress scheduler Christina Knowles; everyone who participated in the making of the Educate Congress video, especially Paul Noble and Anthony Cupaiuolo (bro!); and Malcolm Woods, who helped organize the Educate Congress launch at the National Press Club and kept the word going on Twitter (with the aid of “The West Wing” staff). All of you made this happen!

Erin Thornton, Christy Turlington Burns (holding the film “No Woman, No Cry”) Rep. Gary Peters, Judy Norsigian, Allyson Reddy, and Grace Adofoli

“Makers: Women Who Make America,” the PBS/AOL documentary, debuts tonight on PBS at 8 p.m. (check local listings). If you’re on Twitter, join the discussion during the broadcast at #MAKERSchat.

Narrated by Meryl Streep, the film covers the last 50 years of the women’s movement — the accomplishments and setbacks that followed the publication of “The Feminine Mystique.”

“Most of us have seen the old television commercials before, those 1950s ads that marketed products by telling women how stupid and disappointing they were. So, in the beginning, this program feels like old news (one generation has seen it all before, and the other doesn’t care), but the narrative quickly comes together and still has the power to astound,” writes Anita Gates in The New York Times.

Extended Interviews Online
“Our Bodies, Ourselves” founders Judy Norsigian and Miriam Hawley were interviewed for Makers about the medical and social conditions that prompted a group of women to research, publish and distribute their own findings on women’s health and sexuality. Their interviews are available online.

“You have to understand that back in the late 60s, 98 percent of OB-GYNS were male. About 90 percent of all physicians were male. There was a tremendous amount of condescencion and paternalism,” says Norsigian, who is also executive director of the organization Our Bodies Ourselves.

“I remember one doctor saying to me, dear dear, you’re a smart intelligent woman — you ought to have more children,” says Hawley, later noting, “I kept saying we’re going to sell a million copies. And people kept laughing till we did.”

Produced by filmmakers Dyllan McGee, Betsy West and Peter Kunhardt, the Makers website proclaims to have the largest video collection of women’s stories. It is quite a mix. Browse through the offerings and you’ll find author Alice Walker, food pioneer Alice Waters, racecar driver Danica Patrick, artist/architect May Lin, comic creator Cathy Guisewite, actress Rita Moreno, former college president Ruth Simmons, and coal miner Barbara Burns, who fought sexual harassment in the workplace.

And, of course, Gloria Steinem.

And, suprisingly, Phyllis Schlafly.

Women’s Health Activism
Some of our colleagues in health activism are featured, including Susan Love, who discusses innovative breast cancer research as well as her own coming out story:   “Living out loud really allows you to be who are and to get into the work you need to do as opposed to spending a lot of time trying to protect yourself.”

Byllye Avery, founder of the Black Women’s Health Project (now the Black Women’s Health Imperative) and co-founder of Raising Women’s Voices, discusses access to abortion and opening a women’s health clinic in Florida — and working to “de-medicalize” the interior with shag carpeting, posters on the ceiling, and pot holders on the stirrups (to eliminate the chill). She also addresses the importance of community and self-care on multiple levels.

“Once you can get the emotional stuff straight, then you can start talking about the body,” says Avery. “Because if I’m worrying about someone coming home and beating me, I’m hardly thinking about I haven’t had a pap smear in five years.”

Sharing personal stories, Avery reminisces about her late husband, who died suddenly of a heart attack in 1970. Before his death, he recommended “The Feminine Mystique,” which he thought she would appreciate.

“I hated that I didn’t read it before he died so we could have had some discussions, ’cause I could have confronted him about the dishes,” she said.

New Voices, New Issues
Makers.com is a historian’s treasure trove, yet it also covers history in the making with the inclusion of younger women like media creator Tavi Gevinson, editor of Rookie magazine (Gevinson praised the new “Our Bodies, Ourselves“), feminist organizer Shelby Knox, and youth organizer Maritza Alarcón, whose energy about her work is infectious.

The Makers blog has pulled together quotes around timely themes, such as “5 Views on Job Flexibility” and “5 Views on Women in Film– Past, Present and Future.”

One of Norsigian’s online interview segments addresses finding support, and she concludes with this advice:

“Don’t go it alone, if possible. Get in place the kinds of friends and families around you that will make it possible to be a good parent, a good co-worker, and to contribute to the community around you. I think it’s important that we find space to be part of a larger community, that we don’t just see ourselves as part of a nuclear family.”

Updated to reflect that the OBOS interviews are available online and not in the film itself.

The Centers for Disease Control and Prevention (CDC) recently released the first-ever set of national data focused on intimate partner violence, sexual violence, and stalking victimization by sexual orientation.

According to the findings, lesbians and gay men experience higher rates of partner and sexual violence than do heterosexuals, and bisexual women have significantly higher lifetime prevalence rates of rape and sexual violence committed by any perpetrator (that could include an intimate partner, family member, acquaintance or stranger.)

The data, gathered from the National Intimate Partner and Sexual Violence Survey, includes responses from almost 10,000 women; here’s a FAQ about the findings and methodology.

“We know that violence affects everyone, regardless of sexual orientation. This report suggests that lesbians, gay men and bisexuals in this country suffer a heavy toll of sexual violence and stalking committed by an intimate partner,” CDC Director Tom Frieden said in a release. “While intervening and providing services are important, prevention is equally critical.”

Among the findings:

• 43.8% of lesbian women, 61.1% of bisexual women, and 35.0% of heterosexual women had experienced rape, physical violence, and/or stalking by an intimate partner.
• Approximately 1 in 8 lesbians (13.1%), nearly half of bisexual women (46.1%), and 1 in 6 heterosexual women (17.4%) have been raped in their lifetime (translating to about 214,000 lesbians, 1.5 million bisexual women, and 19 million heterosexual women).
• 1 in 3 bisexual women and 1 in 6 heterosexual women (15.5%) have experienced stalking victimization at some point during their lifetime. (Numbers were too small to be reliable for lesbian women.)
• More than one-third of lesbians (36.3%), over half of bisexual women (55.1%), and more than one-quarter of heterosexual women (29.8%) have been slapped, pushed, or shoved by an intimate partner at some point in their lifetime.
• 23.6% of heterosexual women, 29.4% of lesbian women, and 49.3% of bisexual women had experienced severe physical violence by an intimate partner (e.g., hit with fist or something hard, slammed against something, or beaten).
• The majority of women who reported experiencing sexual violence, regardless of their sexual orientation, reported that they were victimized by male perpetrators. Most bisexual and heterosexual women (89.5% and 98.7%, respectively) reported having only male perpetrators of intimate partner violence.

Neither the full report nor the sexual orientation report provide information about intimate partner violence related to gender identity, although transgender women and men may be more likely to experience severe partner violence. The CDC notes that the Department of Health and Human Services is working on “developing standardized measures of sexual orientation and gender identity” to include in national surveys like this one in order to collect better data.

The National Coalition of Anti-Violence Programs provides some related information in its report, “Lesbian, Gay, Bisexual, Transgender, Queer, and HIV-Affected Intimate Partner Violence, 2011,” using data collected from member and affiliate programs — this limits the data, though, to LGBTQH-identified people who actually sought help from one of the programs.

It’s fairly clear, as the CDC explains, that “more research as well as ongoing data collection is needed,” and that violence against non-heterosexual, non-cisgender populations remains a major concern.

Meanwhile, House Republicans last week introduced their own version of the Violence Against Women Act without provisions for LGBT, Native American, and immigrant populations. We’re still waiting for Congress to do the right thing and pass an inclusive version.

Related: No Country for All Women: Holding Up Violence Against Women Act

The Selling Sickness 2013 conference is taking place in Washington, D.C. this week, focusing on the idea of “disease mongering,” or defining health and disease in a way that promotes the sales of drugs and other treatments that may be unnecessary.

Discussion topics include a number of subjects related to women’s health, including increased or inappropriate use of drugs for conditions such as osteopenia (NPR did an excellent story a few years back on the creation of osteopenia as a disease and the drugs marketed to treat it); the problems with routine screening, such as using mammograms to detect breast cancer; and a workshop on unanswered questions on HPV vaccinations.

The conference is attracting academics, health journalists, consumer advocates, and others. Today’s line-up includes a roundtable on the women’s health movement chaired by Harriet Rosenberg of York University. From the description:

The women’s health movement that began in the 1960s challenged the status quo of medicine and heathcare across the board: clinical research, clinical practice, treatment approvals, trial conduct, pt-dr relations, patient education, disease funding, patient rights … it was a revolution. this roundtable will bring the Whm up to date and discuss what it has to offer current issues.

Participants include Colleen Fuller, Canadian Centre for Policy Alternatives; Anne Rochon Ford, Canadian Women’s Health Network; Cynthia Pearson, National Women’s Health Network; Gail Hornstein PhD, Mount Holyoke College; and Kay Dickersin, Consumers United for Evidence-Based Healthcare.

On Friday, Pearson will be joined by NWHN staff members Amy Allina and Kate Ryan to lead a symposium on “Fighting Disease-Mongering with Evidence to Protect Women’s Health.”

You can check in with the conference from afar by following @sellingsickness and the hashtag #sellingsickness on Twitter. Updates are also being posted on the conference Facebook page.